Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, whether he is taking steps to licence ACT-O-VIAL containing 100mg hydrocortisone sodium succinate (powder) and 2ml of water (diluent), in the context of the discontinuation of the liquid form of hydrocortisone sodium phosphate.

The Medicines and Healthcare products Regulatory Agency (MHRA) recognises the concerns raised about the withdrawal of the previously marketed liquid hydrocortisone injection.

Following a review of our current regulatory position, we can confirm that any marketing authorisation application for a liquid hydrocortisone injection product submitted to the MHRA will be rapidly progressed. A licensed hydrocortisone sodium succinate powder for solution for injection remains authorised.

ACT-O-VIAL containing 100 milligrams hydrocortisone sodium succinate, as a powder, and two millilitres of water, as a diluent, does not have a United Kingdom licence. Should a company choose to submit an application for such a product, the MHRA would prioritise its assessment, recognising the clear clinical importance. However, decisions regarding the development, manufacture, and marketing of medicines rest solely with the companies that hold, or seek to hold, the relevant product licences. The MHRA cannot compel companies to supply a medicine.